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A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

Last updated on March 25, 2018

FOR MORE INFORMATION
Study Location
Georgetown University Medical Center
Washington, District of Columbia, 20007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically confirmed advanced RCC with predominantly clear-cell
subtype with primary tumor resected

- At least one measureable lesion as defined by Response Evaluation Criteria In Solid
Tumors (RECIST) version 1.1.

- Eastern Cooperative Oncology Group performance status 0 or 1

- Controlled hypertension

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with systemic therapy for advanced RCC

- Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred
during or within 12 months after the last dose of treatment

- Prior treatment with any agent specifically targeting T-cell co-stimulation or
checkpoint pathways

- Active seizure disorder or evidence of brain metastases, spinal cord compression, or
carcinomatous meningitis

- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of
randomization except for adequately treated basal cell or squamous cell skin cancer,
or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with
no plans for treatment intervention

- In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,
or transient ischemic attack

- In past 6 months: deep vein thrombosis or pulmonary embolism

NCT02133742
Pfizer
Active, not recruiting
A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer
A Phase 1b, Open Label, Dose Finding Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of Axitinib (Ag-013736) In Combination With Pembrolizumab (Mk-3475) In Patients With Advanced Renal Cell Cancer
Despite substantial improvements of patients outcome in advanced RCC, durable and complete response is uncommon. The majority of patients eventually develop resistance and exhibit disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with axitinib may provide additional clinical benefit compared to axitinib alone.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Drug: Axitinib
    Axitinib at starting dose of 5 mg and 3 mg BID.
  • Drug: MK-3475
    MK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase.
Experimental: Dose finding phase and dose expansion phase
To test the maximum tolerated dose of MK-3475 at 2 mg/kg every three weeks intravenous infusion in combination with approved axitinib dose
Interventions:
  • Drug: Axitinib
  • Drug: MK-3475
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
April 2018
March 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype with primary tumor resected
  • At least one measureable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Controlled hypertension

Exclusion Criteria:

  • Prior treatment with systemic therapy for advanced RCC
  • Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
  • Prior treatment with any agent specifically targeting T-cell co-stimulation or checkpoint pathways
  • Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
  • Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of randomization except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with no plans for treatment intervention
  • In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
  • In past 6 months: deep vein thrombosis or pulmonary embolism
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02133742
A4061079
No
Not Provided
Not Provided
Pfizer
Pfizer
Merck Sharp & Dohme Corp.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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